56344 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

(Approved by the Office of Management and 

Budget under control number 0580–0016) 

James E. Link, 

Administrator, Grain Inspection, Packers and 

Stockyards Administration. 

[FR Doc. 06–8268 Filed 9–26–06; 8:45 am] 

BILLING CODE 3410–KD–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 70 

RIN 3150–AH96 

Facility Change Process Involving 

Items Relied on for Safety 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Direct final rule. 

SUMMARY: The Nuclear Regulatory 

Commission (NRC) is amending its 

regulations to clarify a requirement 

pertaining to items relied on for safety 

(IROFS). This rulemaking corrects an 

inconsistency in the regulations 

pertaining to IROFS. 

DATES: The final rule is effective on 

December 11, 2006, unless significant 

adverse comments are received by 

October 27, 2006. As detailed in the 

Procedural Background section, a 

significant adverse comment is a 

comment where the commenter 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. If the 

NRC receives any significant adverse 

comments, the NRC will publish a 

document that withdraws the direct 

final rule and addresses the comments 

received in a final rule as a response to 

the companion proposed rule published 

elsewhere in this issue of the Federal 

Register. 

ADDRESSES: You may submit comments 

by any one of the following methods. 

Please include the following number 

(RIN 3150–AH96) in the subject line of 

your comments. Comments on 

rulemakings submitted in writing or in 

electronic form will be made available 

for public inspection. Because your 

comments will not be edited to remove 

any identifying or contact information, 

the NRC cautions you against including 

personal information such as social 

security numbers and birth dates in 

your submission. 

Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

E-mail comments to: SECY@nrc.gov. If 

you do not receive a reply e-mail 

confirming that we have received your 

comments, contact us directly at (301) 

415–1966. You may also submit 

comments via the NRC’s rulemaking 

Web site at http://ruleforum.llnl.gov. 

Address questions about our rulemaking 

website to Carol Gallagher (301) 415–

5905; e-mail cag@nrc.gov. Comments 

can also be submitted via the Federal 

eRulemaking Portal http:// 

www.regulations.gov. 

Hand deliver comments to: 11555 

Rockville Pike, Rockville, Maryland 

20852, between 7:30 a.m. and 4:15 p.m. 

Federal workdays. (Telephone (301) 

415–1966). 

Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at (301) 

415–1101. 

Publicly available documents related 

to this rulemaking may be viewed 

electronically on the public computers 

located at the NRC’s Public Document 

Room (PDR), O1 F21, One White Flint 

North, 11555 Rockville Pike, Rockville, 

Maryland. The PDR reproduction 

contractor will copy documents for a 

fee. Selected documents, including 

comments, may be viewed and 

downloaded electronically via the NRC 

rulemaking Web site at http:// 

ruleforum.llnl.gov. 

Publicly available documents created 

or received at the NRC after November 

1, 1999, are available electronically at 

the NRC’s Electronic Reading Room at 

http://www.nrc.gov/reading-rm/ 

adams.html. From this site, the public 

can gain entry into the NRC’s 

Agencywide Document Access and 

Management System (ADAMS), which 

provides text and image files of NRC’s 

public documents. If you do not have 

access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS, contact the NRC 

PDR Reference staff at 1–800–397–4209, 

301–415–4737 or by e-mail to 

pdr@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Anthony N. Tse, Office of Nuclear 

Material Safety and Safeguards, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, telephone 

(301) 415–6233, e-mail ant@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

NRC’s regulations at 10 CFR part 70 

govern the domestic licensing of special 

nuclear material (SNM), including the 

licensing of uranium enrichment 

facilities. On September 18, 2000 (65 FR 

56211), the NRC added subpart H 

requirements (§§ 70.60 to 70.76) to 10 

CFR part 70. Subpart H applies to 

licensees possessing greater than a 

critical mass of SNM, such as those 

engaged in enriched uranium 

processing, fabrication of uranium fuel 

or fuel assemblies, enriched uranium 

hexafluoride conversion, plutonium 

processing, fabrication of mixed-oxide 

fuel or fuel assemblies, and the scrap 

recovery of SNM. Section 70.61 sets 

forth performance requirements, and 

requires that the controls needed to 

meet the performance requirements be 

designated as IROFS. Section 70.62 

requires the establishment of a safety 

program based on an integrated safety 

analysis (ISA). Under § 70.65, a 

summary of the ISA must be submitted 

to the NRC for approval, and the 

summary must contain the IROFS upon 

which the licensee relies in order to 

meet the performance requirements. In 

§ 70.4, the definition of IROFS specifies 

that, in addition to the IROFS needed to 

meet the performance requirements in 

§ 70.61 (i.e., the minimum set), a 

licensee may designate additional 

IROFS (i.e., beyond those in the 

minimum set necessary for compliance 

with the performance requirements). 

The only revision to the subpart H 

requirements now being made is to 10 

CFR 70.72(c)(2), as discussed further in 

this document. 

Discussion 

Section 70.72 contains requirements 

which control changes licensees (subject 

to subpart H) make to their facilities, 

and specifies criteria for determining if 

these changes require the NRC staff’s 

review and approval before they are 

made. Section 70.72(c)(2) specifies that 

a licensee may remove an IROFS that is 

listed in the ISA summary, without 

prior NRC approval, if the licensee 

replaces the IROFS with an equivalent 

replacement of the safety function. 

Unlike other subpart H provisions (i.e., 

§ 70.72(c)(3) and paragraphs (a)(4) and 

(a)(5) of Appendix A to Part 70), which 

distinguish between the minimum set of 

IROFS needed to meet the performance 

requirements and the larger set of IROFS 

a licensee may choose to identify, 

§ 70.72(c)(2) does not make this 

distinction in stating as follows: 

(c) The licensee may make changes to the 

site, structures, processes, systems, 

equipment, components, computer programs, 

and activities of personnel, without prior 

Commission approval, if the change * * * 

(2) Does not remove, without at least an 

equivalent replacement of the safety 

function, an item relied on for safety that is 

listed in the integrated safety analysis 

summary. 

Questions have arisen about whether 

changes involving licensee-identified 

IROFS that are not needed to meet the 


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Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 56345 

performance requirements in § 70.61 

require an equivalent replacement of the 

safety function. 

The staff is thus adding the phrase 

‘‘and is necessary for compliance with 

the performance requirements of 

§ 70.61’’ to the end of § 70.72(c)(2). 

This revision clarifies that if an IROFS 

is not needed to meet the § 70.61 

performance requirements, a licensee 

may remove or replace the IROFS 

without NRC staff’s approval and 

without showing equivalent 

replacement of the safety function. This 

change does not affect IROFS needed to 

meet performance requirements. If a 

licensee intends to remove or replace an 

IROFS needed to meet performance 

requirements, then the licensee must 

obtain NRC staff’s pre-approval before 

making the change, unless the licensee 

has demonstrated with on-site 

documentation that the replacement or 

removal of the IROFS could be done 

with equivalent replacement of the 

safety function of the IROFS. 

Procedural Background 

This rulemaking will become effective 

on December 11, 2006. However, if the 

NRC receives significant adverse 

comments by October 27, 2006, the NRC 

will publish a document that withdraws 

the direct final rule and addresses the 

comments received in a final rule as a 

response to the companion proposed 

rule published elsewhere in this issue of 

the Federal Register. Absent significant 

modifications to the proposed revisions 

requiring republication, the NRC will 

not initiate a second comment period on 

this action. 

A significant adverse comment is a 

comment where the commenter 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. A 

comment is adverse and significant if: 

(1) The comment opposes the rule and 

provides a reason sufficient to require a 

substantive response in a notice-andcomment process. For example, a 

substantive response is required when: 

(a) The comment causes the NRC staff 

to reevaluate (or reconsider) its position 

or conduct additional analysis; 

(b) The comment raises an issue 

serious enough to warrant a substantive 

response to clarify or complete the 

record; or 

(c) The comment raises a relevant 

issue that was not previously addressed 

or considered by the NRC staff. 

(2) The comment proposes a change 

or an addition to the rule, and it is 

apparent that the rule would be 

ineffective or unacceptable without 

incorporation of the change or addition. 

(3) The comment causes the staff to 

make a change (other than editorial) to 

the rule. 

Agreement State Compatibility 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997, and 

published in the Federal Register on 

September 3, 1997 (62 FR 46517), this 

portion of regulations is designated 

Category ‘‘NRC’’ and therefore is not a 

matter of Compatibility. 

Plain Language 

The Presidential Memorandum dated 

June 1, 1998, entitled, ‘‘Plain Language 

in Government Writing’’ directed that 

the Government’s writing be in plain 

language. The NRC requests comments 

on this direct final rule specifically with 

respect to the clarity and effectiveness 

of the language used. Comments should 

be sent to the address listed under the 

heading ADDRESSES above. 

Voluntary Consensus Standards 

The National Technology Transfer Act 

of 1995 (Pub. L. 104–113) requires that 

Federal agencies use technical standards 

that are developed or adopted by 

voluntary consensus standards bodies 

unless the use of such a standard is 

inconsistent with applicable law or 

otherwise impractical. In this direct 

final rule, the NRC is amending its 

regulations to clarify that the 

requirement in § 70.72(c)(2) applies only 

to the set of IROFS that are necessary to 

meet the § 70.61 performance 

requirements (i.e., the minimum set), 

and does not apply to IROFS beyond 

those in the minimum set. This action 

does not constitute the establishment of 

a standard that establishes generally 

applicable requirements. 

Environmental Impact: Categorical 

Exclusion 

The NRC has determined that this 

direct final rule is the type of action 

described in categorical exclusion 10 

CFR 51.22(c)(2). Therefore neither an 

environmental impact statement nor an 

environmental assessment has been 

prepared for this direct final rule. 

Paperwork Reduction Act Statement 

This direct final rule decreases the 

burden on licensees to update the onsite documentation when a change 

covered by § 70.72 is made. The annual 

public burden reduction for this 

information collection is estimated to 

average 10 hours for each 8 licensees. 

Because the burden for this information 

collection is insignificant, Office of 

Management and Budget (OMB) 

clearance is not required. Existing 

requirements were approved by the 

Office of Management and Budget, 

approval number 3150–0009. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

Regulatory Analysis 

A regulatory analysis has not been 

prepared for this direct final rule 

because this rule is considered a minor 

non-substantive amendment; it has 

insignificant economic impact on NRC 

licensees and the public. 

Regulatory Flexibility Certification 

In accordance with the Regulatory 

Flexibility Act of 1980 (5 U.S.C. 605(b)), 

the Commission certifies that this rule 

does not have a significant economic 

impact on a substantial number of small 

entities. This rule merely makes minor 

changes to the facility change process 

involving items relied on for safety. 

Additionally, the 10 CFR part 70 

subpart H licensees affected by this rule 

are large organizations that do not fall 

within the definition of a small business 

as defined in the Regulatory Flexibility 

Act of the NRC’s regulations (10 CFR 

2.810). 

Backfit Analysis 

The NRC has determined that the 

backfit rule (§§ 50.109, 70.76, 72.62, or 

76.76) does not apply to this direct final 

rule because this amendment does not 

involve any provisions that would 

impose backfits as defined in the backfit 

rule. Therefore, a backfit analysis is not 

required. 

Congressional Review Act 

In accordance with the Congressional 

Review Act of 1996, the NRC has 

determined that this action is not a 

major rule and has verified this 

determination with the Office of 

Information and Regulatory Affairs of 

OMB. 

List of Subjects in 10 CFR Part 70 

Hazardous materials transportation, 

Nuclear materials, Packaging and 

containers, Radiation protection, 

Reporting and recordkeeping 

requirements, Scientific equipment, 

Security measures. 

■ For the reasons set out in the 

preamble and under the authority of the 


sroberts on PROD1PC70 with RULES
56346 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

Atomic Energy Act of 1954, as amended; 

the Energy Reorganization Act of 1974, 

as amended; and 5 U.S.C. 552 and 553; 

the NRC is adopting the following 

amendments to 10 CFR part 70. 

PART 70—DOMESTIC LICENSING OF 

SPECIAL NUCLEAR MATERIAL 

■ 1. The authority citation for part 70 

continues to read as follows: 

Authority: Secs. 51, 53, 161, 182, 183, 68 

Stat. 929, 930, 948, 953, 954, as amended, 

sec. 234, 83 Stat. 444, as amended (42 U.S.C. 

2071, 2073, 2201, 2232, 2233, 2282, 2297f); 

secs. 201, as amended, 202, 204, 206, 88 Stat. 

1242, as amended, 1244, 1245, 1246 (42 

U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 

Stat. 2835 as amended by Pub. L. 104–134, 

110 Stat. 1321, 1321–349 (42 U.S.C. 2243); 

sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 

note). 

Sections 70.1(c) and 70.20a(b) also issued 

under secs. 135, 141, Pub. L. 97–425, 96 Stat. 

2232, 2241 (42 U.S.C. 10155, 10161). Section 

70.7 also issued under Pub. L. 95–601, sec. 

10, 92 Stat. 2951 (42 U.S.C. 5851). Section 

70.21(g) also issued under sec. 122, 68 Stat. 

939 (42 U.S.C. 2152). Section 70.31 also 

issued under sec. 57d, Pub. L. 93–377, 88 

Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 

70.44 also issued under sec. 184, 68 Stat. 954, 

as amended (42 U.S.C. 2234). Section 70.81 

also issued under secs. 186, 187, 68 Stat. 955 

(42 U.S.C. 2236, 2237). Section 70.82 also 

issued under sec. 108, 68 Stat. 939, as 

amended (42 U.S.C. 2138). 

■ 2. In § 70.72, paragraph (c)(2) is 

revised to read as follows: 

§ 70.72 Facility changes and change 

process. 

* * * * * 

(c) * * * 

(2) Does not remove, without at least 

an equivalent replacement of the safety 

function, an item relied on for safety 

that is listed in the integrated safety 

analysis summary and is necessary for 

compliance with the performance 

requirements of § 70.61; 

* * * * * 

Dated at Rockville, Maryland, this 13th day 

of September 2006. 

For the Nuclear Regulatory Commission. 

Luis A. Reyes, 

Executive Director for Operations. 

[FR Doc. 06–8270 Filed 9–26–06; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Amprolium Solution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a new animal drug 

application (ANADA) filed by IVX 

Animal Health, Inc. The ANADA 

provides for use of amprolium solution 

to make medicated drinking water or as 

a drench for the prevention or treatment 

of coccidiosis in calves. 

DATES: This rule is effective September 

27, 2006. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827-0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: IVX 

Animal Health, Inc., 3915 South 48th 

Street Ter., St. Joseph, MO 64503, filed 

ANADA 200–389 that provides for the 

use of Amprolium 9.6% Oral Solution 

to make medicated drinking water or as 

a drench for the prevention or treatment 

of coccidiosis in calves. IVX Animal 

Health’s Amprolium 9.6% Oral Solution 

is approved as a generic copy of Merial 

Ltd.’s CORID (amprolium) 9.6% 

Solution approved under NADA 13–

149. The ANADA is approved as of 

September 6, 2006, and the regulations 

are amended in 21 CFR 520.100 to 

reflect the approval and a current 

format. The basis of approval is 

discussed in the freedom of information 

summary. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

FDA has determined under 21 CFR 

25.33(a)(1) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subject in 21 CFR Part 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Revise § 520.100 to read as follows: 

§ 520.100 Amprolium. 

(a) Specifications—(1) Each milliliter 

of solution contains 96 milligrams (mg) 

amprolium (9.6 percent solution). 

(2) Each gram of powder contains 200 

mg amprolium (20 percent). 

(3) Each ounce (28.4 grams) of 

crumbles contains 355 mg amprolium 

(1.25 percent). 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter. 

(1) No. 050604 for use of products 

described in paragraph (a) of this 

section as in paragraph (e) of this 

section. 

(2) No. 051311 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1) of this 

section. 

(3) No. 059130 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(2) of this 

section. 

(c) Related tolerances. See § 556.50 of 

this chapter. 

(d) Special considerations. See 

§ 500.25 of this chapter. 

(e) Conditions of use—(1) Chickens 

and turkeys. It is used in drinking water 

as follows: 

(i) Amount. Administer at the 0.012 

percent level in drinking water as soon 

as coccidiosis is diagnosed and continue 

for 3 to 5 days (in severe outbreaks, give 

amprolium at the 0.024 percent level); 

continue with 0.006 percent amproliummedicated water for an additional 1 to 

2 weeks. 

(ii)Indications for use. For the 

treatment of coccidiosis. 

(iii) Limitations. Use as the sole 

source of amprolium. 

(2) Calves. Administer crumbles topdressed on or thoroughly mixed in the 


sroberts on PROD1PC70 with RULES